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International Journal of Pulmonary and Respiratory Sciences
Peer Reviewed Journal

Vol. 7, Issue 1, Part A (2025)

Safety and effectiveness of fixed dose combination of formoterol & budesonide inhaler in asthma: A retrospective, real-world observational study

Author(s):

Bharat Toshniwal, Haradatt Karande, Nitin Rathi, Sanjoy Gupta, Shravan Kumar, Swapnil Kulkarni, Suman SV and Ravi T Mehta

Abstract:

Background: Asthma management has improved with inhaled corticosteroids (ICS) and long-acting beta-agonists (LABAs). The fixed-dose combination (FDC) of formoterol and budesonide provides the convenience of a combined therapy, which may enhance adherence and clinical outcomes.
Objectives: To assess the safety and effectiveness of the FDC of formoterol and budesonide in real-world asthma patients.
Methods: This retrospective observational study analysed medical records of patients treated with a formoterol/budesonide inhaler. Key outcomes measured included changes in asthma control, the frequency of exacerbations, and adverse events.
Results: This retrospective study included 5,167 patients with Asthma over an average duration of 3.41 months. The study demonstrated that only 2.84% of patients experienced adverse events, most commonly mild gastrointestinal symptoms such as vomiting (0.93%) and fever (0.56%), while five patients experienced serious adverse events, including severe asthma exacerbations and severe vomiting. The medication showed excellent tolerability, with 81.6% and 79.53% of patients achieving "Very Good" or "Excellent" outcomes as assessed by physicians.
Conclusion: In real-world clinical practice, the combination of formoterol and budesonide inhaler treatment appears to be safe and effective, supporting its use in managing stable and uncontrolled asthma.

Pages: 17-22  |  1115 Views  586 Downloads


International Journal of Pulmonary and Respiratory Sciences
How to cite this article:
Bharat Toshniwal, Haradatt Karande, Nitin Rathi, Sanjoy Gupta, Shravan Kumar, Swapnil Kulkarni, Suman SV and Ravi T Mehta. Safety and effectiveness of fixed dose combination of formoterol & budesonide inhaler in asthma: A retrospective, real-world observational study. Int. J. Pulm. Respir. Sci. 2025;7(1):17-22. DOI: 10.33545/26648504.2025.v7.i1a.32